FDA.reportPublic FDA data

N/A

Primary DI
00841036021511
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
02-5220
Catalog number
02-5220
Published
2017-06-16
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
KATPERFORATOR, ANTRUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KATPerforator, AntrumEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036021511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036021511008410360215118410360215110841036021511

GMDN Terms#

Term, Definition table
TermDefinition
ENT trocar bladeA rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
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
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23
00888233086141Pectus Blu (TM)78-725078-72502026-07-23
00888233086158Pectus Blu (TM)78-730078-73002026-07-23
00888233086165Pectus Blu (TM)78-735078-73502026-07-23
00888233086172Pectus Blu (TM)78-740078-74002026-07-23
00888233086189Pectus Blu (TM)78-745078-74502026-07-23
00888233086196Pectus Blu (TM)78-750078-75002026-07-23
00888233086202Pectus Blu (TM)78-755078-75502026-07-23
00888233086219Pectus Blu (TM)78-800178-80012026-07-23
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653051472AESCULAPAesculap AGKAT2020-05-20
04046964073090AESCULAPAesculap AGKAT2020-04-24
04046964073205AESCULAPAesculap AGKAT2020-04-24
04046964073212AESCULAPAesculap AGKAT2020-04-24
04046964073229AESCULAPAesculap AGKAT2020-04-24
04046964073236AESCULAPAesculap AGKAT2020-04-24
04046964073243AESCULAPAesculap AGKAT2020-04-24
04038653207251AESCULAPAesculap AGKAT2020-04-23
04038653176373AESCULAPAesculap AGKAT2020-04-22
04038653176458AESCULAPAesculap AGKAT2020-04-22
04038653176465AESCULAPAesculap AGKAT2020-04-22
04038653176472AESCULAPAesculap AGKAT2020-04-22
10885403114366V. MuellerCAREFUSION 2200, INCKAT2020-04-15
10885403114335V. MuellerSTERIS CORPORATIONKAT2018-09-10
10885403114427V. MuellerSTERIS CORPORATIONKAT2018-09-10
10885403114328V. MuellerSTERIS CORPORATIONKAT2018-09-10