FDA.reportPublic FDA data

endophix

Primary DI
16974940306076
Brand
endophix
Company
Suzhou Endophix Co., Ltd.
Model
MS-4146B
Published
2025-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974940306076PackageGS15In Commercial Distribution
06974940306079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697494030607616974940306076
06974940306079069749403060796974940306079

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, single-useA cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
620899345
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974940306727endophixMS-15252026-03-03
06974940306758endophixMS-15292026-03-03
06974940306772endophixMS-1535T2026-03-03
06974940306857endophixMS-1529-12026-03-03
06974940306864endophixMS-1529-22026-03-03
06974940306918endophixMS-1525-32026-03-03
06974940307007endophixMS-1529-32026-03-03
06974940307021endophixMS-1525-12026-03-03
06974940307038endophixMS-1525-22026-03-03
06974940307045endophixMS-430620S2025-12-19
06974940307052endophixMS-430820S2025-12-19
06974940307069endophix MS-430840S2025-12-19
06974940307076endophix MS-430860S2025-12-19
06974940307083endophixMS-431020S2025-12-19
06974940307090endophixMS-431050S2025-12-19
06974940306321endophixMS-32022025-12-12
06974940306352endophixMS-32032025-12-12
06974940306369endophixMS-32042025-12-12
06974940306468endophixMS-32052025-12-12
06974940306604endophixMS-32062025-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867614956Arthrex®ARTHREX, INC.GFA2026-05-25
08404535025156LARGE BONE BLADESPeter Brasseler Holdings, LLCGFA2026-03-23
B504OM4515700130DePuy MitekProvisionGFA2026-03-19
B504OM50715940Conmed LinvatecProvisionGFA2026-03-19
B504OMDC119090180Conmed LinvatecProvisionGFA2026-03-19
00810111225366Saw BladeTreace Medical Concepts, Inc.GFA2026-01-26
00810111225342Saw BladeTreace Medical Concepts, Inc.GFA2026-01-07
00810111225335Saw BladeTreace Medical Concepts, Inc.GFA2025-12-18
08681506801180SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIGFA2025-12-12
B39062901120331Reprocessed 3mm Straight Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040601Reprocessed 4mm Angled 60 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
16974940305963endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305970endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305987endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305994endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306007endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306014endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306021endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306038endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
06974940306048endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
06974940306055endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306069endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306083endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306090endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306106endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306113endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306120endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306137endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
00887919258568Large Bone BladePeter Brasseler Holdings, LLCGFA2025-11-26