FDA.reportPublic FDA data

N/A

Primary DI
00889024375406
Brand
N/A
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-7701-003-00
Catalog number
00-7701-003-00
Device description
Autoclave Case
Published
2021-11-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZWExpander, Surgical, Skin Graft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZWExpander, Surgical, Skin GraftGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024375406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024375406008890243754068890243754060889024375406

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
137354267
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024616325Stablecut®XOXCEMTD3PKXOXCEMTD3PK2024-04-09
00889024616332Stablecut®XOXCMTLS3PKXOXCMTLS3PK2024-04-09
00889024647497Stablecut®11-353811-35382023-02-23
00889024647503Stablecut®11-353911-35392023-02-23
00889024647510Stablecut®11-354011-35402023-02-23
00889024647527Stablecut®11-354111-35412023-02-23
00889024647534Stablecut®11-354211-35422023-02-23
00889024647541Stablecut®11-354311-35432023-02-23
00889024647558Stablecut®11-360711-36072023-02-23
00889024647565Stablecut®11-360811-36082023-02-23
00889024647589Stablecut®11-377111-37712023-02-23
00889024647596Stablecut®5061095061092023-02-23
00889024647602Stablecut®5061115061112023-02-23
00889024647619Stablecut®5061425061422023-02-23
00889024647626Stablecut®5061405061402023-02-23
00889024647633Stablecut®5061415061412023-02-23
00889024647640Stablecut® Vanguard™32-70036932-7003692023-02-23
00880304537880Stablecut®5061135061132022-10-03
00880304542464Stablecut®5061145061142022-10-03
00889024493254Stablecut®10070100CR110-0701-00C-R12019-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07445161009494Motiva® Inflatable BalloonEstablishment Labs S.A.FZW2025-06-06
07445161009579Motiva® Inflatable BalloonEstablishment Labs S.A.FZW2025-06-06
07445161009586Motiva® Inflatable BalloonEstablishment Labs S.A.FZW2025-06-06
04049197024686RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
04049197024693RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
04049197024709RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
00810006780123Mesh|ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780130Mesh|Ex EXSURCO MEDICAL, INC.FZW2024-03-20
00810006780147Mesh|ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780154Mesh|ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780185Mesh|ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780192Mesh|ExEXSURCO MEDICAL, INC.FZW2024-03-20
00810006780215Mesh|ExEXSURCO MEDICAL, INC.FZW2024-03-20
06975808860603MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2024-01-22
07540162040429Imperial Stackable StepstoolImperial Surgical LtdFZW2023-07-28
06975808860214MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
06975808860238MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
06975808860313MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.FZW2023-03-16
05033955099015Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099022Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099039Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099046Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099053Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099060Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099091Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099114Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
05033955099121Swann Morton Ltd.SWANN-MORTON LIMITEDFZW2022-09-27
00855638007149Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
00855638007156Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
00855638007163Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10