FDA.reportPublic FDA data

TESS BOTTOM INSERT HEMI

Primary DI
08428898898332
Brand
TESS BOTTOM INSERT HEMI
Company
BIOMET
Model
A1700384
Catalog number
A1700384
Published
2020-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08428898898332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08428898898332084288988983328428898898332

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+0330475759100eufrvra@zimmerbiomet.com

Regulatory Flags#

DUNS number
260930126
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304810990Cement Delivery System1100306231100306232020-04-15
07350023771788Optigun Ratchet4195004195002020-05-23
07350023771719Cement Delivery System414641462021-04-27
03599870107898TESS BASEA1700380A17003802020-05-23
03599870108505T.E.S.S® LIDA1700382A17003822020-05-23
08428898898349TESS TOP INSERT HEMIA1700386A17003862020-05-23
00887868214578BIOMET® BONE CEMENT R1100353681100353682018-04-04
00887868214608BIOMET® BONE CEMENT R1100353711100353712018-04-04
07350023771092Optivac Nozzle Slim415441542019-10-11
07350023771108Optivac Nozzle Revision415541552017-10-09
07350023771214Knee Cementation Nozzle431243122017-10-09
07350023771429Angled Nozzle414941492017-10-09
00880304370326Right-Angle Nozzle4149004149002017-10-09
00880304370562Optivac Total Hip Kit4170004170002017-10-09
00880304370579Optivac Kit, 40 gram single Mix4171004171002017-10-09
00880304370609Optivac Kit, 80 gram Double Mix4172004172002017-10-09
00880304370623Optivac Kit, 120 gram Triple Mix4173004173002017-10-09
00880304370647Optivac Total Hip Kit4180004180002017-10-09
00880304370999Optivac Kit, 80 gram Double Mix4182004182002017-10-09
00880304371002Optivac Kit, 120 gram Triple Mix4183004183002017-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630008405793APTUSMedartis AGFSM2026-07-16
07630008405809APTUSMedartis AGFSM2026-07-16
07630008405878APTUSMedartis AGFSM2026-07-16
07630008405892APTUSMedartis AGFSM2026-07-16
07630008406226APTUSMedartis AGFSM2026-07-16
07630008406233APTUSMedartis AGFSM2026-07-16
07630008406240APTUSMedartis AGFSM2026-07-16
07630008406257APTUSMedartis AGFSM2026-07-16
07630008406264APTUSMedartis AGFSM2026-07-16
07630008406271APTUSMedartis AGFSM2026-07-16
07630008406288APTUSMedartis AGFSM2026-07-16
07630008406295APTUSMedartis AGFSM2026-07-16
07630008406301APTUSMedartis AGFSM2026-07-16
07630008406318APTUSMedartis AGFSM2026-07-16
07630008406325APTUSMedartis AGFSM2026-07-16
07630008406332APTUSMedartis AGFSM2026-07-16
07630008428327APTUSMedartis AGFSM2026-07-16
07630008428334APTUSMedartis AGFSM2026-07-16
07630008453206APTUSMedartis AGFSM2026-07-16
07630008488284APTUSMedartis AGFSM2026-07-16
07630008488314APTUSMedartis AGFSM2026-07-16
07630008488406APTUSMedartis AGFSM2026-07-16
07630037833475APTUSMedartis AGFSM2026-07-16
07630037833482APTUSMedartis AGFSM2026-07-16
07630037846437APTUSMedartis AGFSM2026-07-16
07630037846444APTUSMedartis AGFSM2026-07-16
07630037846697APTUSMedartis AGFSM2026-07-16
07630037846802APTUSMedartis AGFSM2026-07-16
07630037847229APTUSMedartis AGFSM2026-07-16
07630037847236APTUSMedartis AGFSM2026-07-16