FDA.reportPublic FDA data

Stablecut®

Primary DI
00889024494602
Brand
Stablecut®
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
12090119SR1
Catalog number
12-0901-19S-R1
Published
2019-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00889024494602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024494602008890244946028890244946020889024494602

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, reciprocating, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
137354267
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024686120Oxford Surgical BladesOXF3PKXHUBOXF3PKXHUB2026-05-21
00889024686151Oxford Surgical BladesOXF3PKAES3OXF3PKAES32026-05-21
00889024686175Oxford Surgical BladesOXFKLSYKOXFKLSYK2026-05-21
00889024686083Oxford Surgical BladesOXF3PKLINVPOXF3PKLINVP2026-05-20
00889024686090Oxford Surgical BladesOXF3PKLINVVOXF3PKLINVV2026-05-20
00889024686106Oxford Surgical BladesOXF3PKSYKOXF3PKSYK2026-05-20
00889024686113Oxford Surgical BladesOXF3PKSYNOXF3PKSYN2026-05-20
00889024686137Oxford Surgical BladesOXF3PKZIMUOXF3PKZIMU2026-05-20
00889024686144Oxford Surgical BladesOXF3PKDESMOXF3PKDESM2026-05-20
00889024686168Oxford Surgical BladesOXFKLLINOXFKLLIN2026-05-20
00889024686182Oxford Surgical BladesOXFKLSYNOXFKLSYN2026-05-20
00889024686199Oxford Surgical BladesOXFKLZIMBOXFKLZIMB2026-05-20
00889024686205Oxford Surgical BladesOXFKLAESCOXFKLAESC2026-05-20
00889024375901Dermatome00-8801-001-0000-8801-001-002021-03-03
00889024464834Dermatome88710100887101002017-01-26
00889024626447A.T.S.® Personalized Pressure®60320010100603200101002023-08-30
00889024626454A.T.S.® Personalized Pressure®60-5000-101-00605000101002022-03-30
00889024375024PULSAVAC®00-5150-350-0000-5150-350-002016-08-12
00889024375031PULSAVAC®00-5150-350-0100-5150-350-012016-08-12
00889024375048PULSAVAC®00-5150-350-0200-5150-350-022016-08-12

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
16974940306076endophixSuzhou 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