FDA.report

NA

Primary DI
00889024325432
Brand
NA
Company
ZIMMER SPINE, INC.
Model
07.01332.001
Published
2016-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FSTLIGHT, SURGICAL, FIBEROPTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024325432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024325432008890243254328890243254320889024325432

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)774-6368zimmer.consumerrelations@zimmer.com

Regulatory Flags

DUNS number
787663400
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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