FDA.reportPublic FDA data

TOTALSHIELD®

Primary DI
00889024464698
Brand
TOTALSHIELD®
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-9910-301-12
Catalog number
00-9910-301-12
Device description
Surgical Hood
Published
2017-11-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGOWN, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024464698PackageGS136In Commercial Distribution
00889024464681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024464698008890244646988890244646980889024464698
00889024464681008890244646818890244646810889024464681

GMDN Terms#

Term, Definition table
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 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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024686120Oxford Surgical BladesOXF3PKXHUBOXF3PKXHUB2026-05-21
00889024686151Oxford Surgical BladesOXF3PKAES3OXF3PKAES32026-05-21
00889024686175Oxford Surgical BladesOXFKLSYKOXFKLSYK2026-05-21
00889024686083Oxford Surgical BladesOXF3PKLINVPOXF3PKLINVP2026-05-20
00889024686090Oxford Surgical BladesOXF3PKLINVVOXF3PKLINVV2026-05-20
00889024686106Oxford Surgical BladesOXF3PKSYKOXF3PKSYK2026-05-20
00889024686113Oxford Surgical BladesOXF3PKSYNOXF3PKSYN2026-05-20
00889024686137Oxford Surgical BladesOXF3PKZIMUOXF3PKZIMU2026-05-20
00889024686144Oxford Surgical BladesOXF3PKDESMOXF3PKDESM2026-05-20
00889024686168Oxford Surgical BladesOXFKLLINOXFKLLIN2026-05-20
00889024686182Oxford Surgical BladesOXFKLSYNOXFKLSYN2026-05-20
00889024686199Oxford Surgical BladesOXFKLZIMBOXFKLZIMB2026-05-20
00889024686205Oxford Surgical BladesOXFKLAESCOXFKLAESC2026-05-20
00889024375901Dermatome00-8801-001-0000-8801-001-002021-03-03
00889024464834Dermatome88710100887101002017-01-26
00889024626447A.T.S.® Personalized Pressure®60320010100603200101002023-08-30
00889024626454A.T.S.® Personalized Pressure®60-5000-101-00605000101002022-03-30
00889024375024PULSAVAC®00-5150-350-0000-5150-350-002016-08-12
00889024375031PULSAVAC®00-5150-350-0100-5150-350-012016-08-12
00889024375048PULSAVAC®00-5150-350-0200-5150-350-022016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
20888277720050MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
20888277419879MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277419886MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277660905MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674704MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674711MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674735MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
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09009607832220ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
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