FDA.reportPublic FDA data

MediChoice

Primary DI
30885632065419
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
SG0001
Device description
Suture Guide Curved 8 Numbered A And B Slots Single Patient Use, Sterile White Hdpe Base, Blue Pvc Insert, White Foam Tape With High Tack Adhesive, White Paper Liner 3 Per Pack MediChoice
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
30885632065419PackageGS14In Commercial Distribution
20885632065412PrimaryGS10
10885632065415Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088563206541930885632065419
2088563206541220885632065412
1088563206541510885632065415

GMDN Terms#

Term, Definition table
TermDefinition
Operative-site suture holderA device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
Device count
3
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18
10885632521577SurgiTrackSM450041BC2C2026-05-18
10885632521584SurgiTrackSM45004117402026-05-18
10885632521591SurgiTrackSM45004113802026-05-18
10885632521317SurgiTrackSM450178CA972026-05-13
10885632434228Halyard563442026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00887482054925Symmetry DeschampsASPEN SURGICAL PRODUCTS, INC.GEJ2024-08-15