FDA.reportPublic FDA data

SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

Primary DI
07540194008411
Brand
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
Company
Pega Medical Inc
Model
GIN-JCH100
Catalog number
GIN-JCH100
Device description
JACOBS CHUCK T-HANDLE PINK
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194008411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194008411075401940084117540194008411

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(450)688-5144egarcia@pegamedical.com

Regulatory Flags#

DUNS number
257315713
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540194017949GIRO GROWTH MODULATION SYSTEMGRO-CYE200-35GRO-CYE200-352025-03-31
07540194017956GIRO GROWTH MODULATION SYSTEMGRO-CYF250-35GRO-CYF250-352025-03-31
07540194009678FREE GLIDING SCFE SCREW SYSTEMSCF-CSIN525SCF-CSIN5252024-09-11
07540194012050SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMPEG-CFL-20PEG-CFL-202024-09-11
07540194012067SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMPEG-CFL-24PEG-CFL-242024-09-11
07540194012074SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMPEG-CFL-28PEG-CFL-282024-09-11
07540194014238FASSIER-DUVAL TELESCOPIC IM SYSTEMFC-CUT100FC-CUT1002024-09-11
07540194015853HINGE PEDIATRIC PLATING SYSTEMHP-CSF250HP-CSF2502024-09-11
07540194015907HINGE PEDIATRIC PLATING SYSTEMHP-CYF250HP-CYF2502024-09-11
07540194015921GIRO GROWTH MODULATION SYSTEMGRO-CYF150-45GRO-CYF150-452024-09-11
07540194015945GIRO GROWTH MODULATION SYSTEMGRO-CYF150-60GRO-CYF150-602024-09-11
07540194015976Dr.Paleys Osteotomy SystemDRPBC-201DRPBC-2012024-09-11
07540194015990FASSIER-DUVAL TELESCOPIC IM SYSTEMFC-KNB100FC-KNB1002024-09-11
07540194016034Dr.Paleys Osteotomy SystemDRPFO-201DRPFO-2012024-09-11
07540194016041Dr.Paleys Osteotomy SystemDRPCP-201DRPCP-2012024-09-11
07540194016607GAP ENDO-EXO MEDULLARY SYSTEMGAP-TMP200GAP-TMP2002024-09-11
07540194016799GAP ENDO-EXO MEDULLARY SYSTEMGAP-RSC200GAP-RSC2002024-09-11
07540194016836GAP ENDO-EXO MEDULLARY SYSTEMGAP-IME200GAP-IME2002024-09-11
07540194016843GAP ENDO-EXO MEDULLARY SYSTEMGAP-IMF200GAP-IMF2002024-09-11
07540194016867GAP ENDO-EXO MEDULLARY SYSTEMGAP-IME250GAP-IME2502024-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00841523181360Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181681Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181698Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181704Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181711Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181728Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181735Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181742Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181759Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181766Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181773Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181780Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181797Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181803Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181827Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181834Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181841Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181858Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26