FDA.report

TOTALSHIELD®

Primary DI
00889024376403
Brand
TOTALSHIELD®
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-9900-104-00
Catalog number
00-9900-104-00
Device description
Battery Holster
Published
2016-08-12
Public version status
Update
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
FYAGOWN, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024376403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024376403008890243764038890243764030889024376403

GMDN Terms

TermDefinition
Surgical helmet systemA system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.

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
false
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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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 DIBrandCompanyProduct codePublished
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00634916788129Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789249ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789256ProMax Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789263ProMax Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916792775OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796322ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796339ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
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00634916880816ComPel Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880823ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916899627ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
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