FDA.reportPublic FDA data

ADJUSTER

Primary DI
00888118026002
Brand
ADJUSTER
Company
KLS-Martin L.P.
Model
20-886-23-07
Device description
LIGATURE
Published
2018-09-26
Public version status
Update
Distribution status
Not 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
GEJCARRIER, LIGATURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEJCarrier, LigatureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118026002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118026002008881180260028881180260020888118026002

GMDN Terms#

Term, Definition table
TermDefinition
Suture knot pusher, reusableA hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
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
00888118086037SILICONE MAT55-348-01-012020-06-19
00888118125729TRAY55-804-25-012020-06-19
00888118003119CARRIER00-105-92-072018-09-26
00888118006974CURETTE01-500-01-072018-09-26
00888118006981CURETTE01-500-02-072018-09-26
00888118006998CURETTE01-500-03-072018-09-26
00888118008626CALIPER04-407-20-072018-09-26
00888118009012SCOPE HOLDER ARM07-001-42-072016-09-20
00888118009029SCOPE HOLDER CLAMP07-001-43-072016-09-20
00888118009050SCOPE HOLDER ARM07-001-49-072016-09-20
00888118022950PHLEBEXTRACTOR16-249-02-072018-09-26
00888118022967PHLEBEXTRACTOR16-249-03-072018-09-26
00888118022981STRIPPER16-251-02-012018-09-26
00888118022998STRIPPER16-251-03-012018-09-26
00888118023001STRIPPER16-251-04-012018-09-26
00888118023018STRIPPER16-251-06-012018-09-26
00888118023025STRIPPER16-251-07-012018-09-26
00888118023032STRIPPER16-251-08-012018-09-26
00888118023049STRIPPER16-251-10-012018-09-26
00888118023056STRIPPER16-251-14-012018-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397173MillenniumAvalign Technologies, Inc.GEJ2026-07-16
16975808861300MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861317MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861324MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861331MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861348MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861355MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861362MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861379MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
16975808861386MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861303MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861310MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861327MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861334MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861341MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861358MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861365MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861372MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
06975808861389MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GEJ2026-05-13
10840113298782CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
10840113299765CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
20840113299076CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
00814707024043CygnusASPEN SURGICAL PRODUCTS, INC.GEJ2026-04-09
00194613014438MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2025-08-01
00194613063443MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091439MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091484MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00887482041444Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482041451Symmetry DeschASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15
00887482054918Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15