FDA.report

N/A

Primary DI
00889024367357
Brand
N/A
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-0056-008-00
Catalog number
00-0056-008-00
Device description
Polyester Pile Knee Sling
Published
2020-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
HSTApparatus, Traction, Non-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024367357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024367357008890243673578890243673570889024367357

GMDN Terms

TermDefinition
Knee slingA hanging band, typically suspended from an overhanging structure, intended to be used to cradle a knee to support and limit the range of motion of an injured knee/leg during healing. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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
true
Serial number
false
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

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