FDA.reportPublic FDA data

SROM Extractor Loop Adapter

Primary DI
00847538010497
Brand
SROM Extractor Loop Adapter
Company
SYMMETRY MEDICAL INC.
Model
12-050-000
Catalog number
2709-03-008
Device description
SROM Extractor Loop Adapter
Published
2022-05-10
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

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
00847538010497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847538010497008475380104978475380104970847538010497

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079881212
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00847538005479Patella Caliper802-01-1122025-12-10
00847538009415Short Fin Osteotome Blade11-136-5012500-10-7562024-06-28
00847538008654HP Extraction Standard Removal Case87-10082011-03-0482023-11-28
00847538009330Long Radial Osteotome Blade11-127-5032500-10-7552023-10-23
00847538009293Short Radial Osteotome Blade11-127-5012500-10-7532023-09-22
00847538009316Medium Radial Osteotome Blade11-127-5022500-10-7542023-09-22
00847538009354Long Flat Osteotome Blade11-130-5012500-10-7522023-09-22
00847538009378Medium Flat Osteotome Blade11-130-5022500-10-7512023-09-22
00847538018721GLOBAL UNITE™ Short Stem Instrumentation2128118002021-09-01
00847538018738GLOBAL UNITE™ Short Stem Instrumentation2128111002021-09-01
00847538018745GLOBAL UNITE™ Short Stem Instrumentation2128111202021-09-01
00847538018769GLOBAL UNITE™ Short Stem Instrumentation2128111402021-09-01
00847538018776GLOBAL UNITE™ Short Stem Instrumentation2128111602021-09-01
00847538015256Flexible Osteotome System with Radel Case30-005-0002709-04-000; 30-005-000-15002023-07-17
00847538019179Femoral Tray30-037-4002709-01-000; 30-037-400-15002023-07-17
00817766026423GLOBAL UNITE™ Short Stem Instrumentation2236002112021-09-01
00847538004236Adapter Shaft AO Small To Hudson09-159-0002810010302022-07-22
00847538001006Flag Splitter10-001-00000-9986-010-12;4300012022-05-12
00847538018868Cutting Pliers74-388-0002312201142022-07-12
00847538018882Large Fragment Bone Clamp74-294-0008162990112022-07-12

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