FDA.reportPublic FDA data

NA

Primary DI
00885554018288
Brand
NA
Company
Smith & Nephew, Inc.
Model
72202931
Catalog number
72202931
Device description
ANKLE STABILIZATION KITS, DISPOSABLE 6 UNITS
Published
2016-08-24
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
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
20885554018282PackageGS16In Commercial Distribution
00885554018288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088555401828220885554018282
00885554018288008855540182888855540182880885554018288

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

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