FDA.report

Integra® Miltex®

Primary DI
H834320000
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
3-2000
Catalog number
3-2000
Device description
Tubing Occlusion Clamp, 1-3/4", Cross-Action, 12 Pack
Published
2018-08-16
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
HXDCLAMP

Product Code Classifications

CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780363583PrimaryGS10
H834320000SecondaryHIBCC0
00381780363586Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178036358310381780363583
00381780363586003817803635863817803635860381780363586

GMDN Terms

TermDefinition
Cannula clampA hand-held manual instrument designed to grasp or compress a cannula. The compression may progress to the point that the cannula is no longer patent. The device is frequently used for temporary partial or complete closing of the cannula in procedures such as cardiopulmonary bypass, haemodialysis, and oral surgery. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
081277700
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10381780544319Codman® CereLink®826820P826820P2025-03-12
10381780524106CODMAN® BACTISEAL®NS0344NS03442024-11-20
10381780525370CODMAN® BACTISEAL®NS5091NS50912024-11-20
10381780521280CODMAN® CERTAS® Plus828807PL82-8807PL2024-11-20
10381780535805CODMAN® CERTAS® Plus828813PL82-8813PL2024-11-20
10381780535843CODMAN® CERTAS® Plus828823PL82-8823PL2024-11-20
10381780535867CODMAN® CERTAS® Plus828827PL82-8827PL2024-11-20
10381780536970CODMAN® BACTISEAL®82174582-17452024-11-20
10381780536987CODMAN® BACTISEAL®82307282-30722024-11-20
10381780536994CODMAN® BACTISEAL®82307382-30732024-11-20
10381780537007CODMAN® BACTISEAL®82307482-30742024-11-20
10381780537014CODMAN® BACTISEAL®82174982-17492024-11-20
10381780537021CODMAN® BACTISEAL®82175082-17502024-11-20
10381780537038CODMAN® BACTISEAL®82308782-30872024-11-20
10381780537045CODMAN® BACTISEAL®82308882-30882024-11-20
10381780537052CODMAN® BACTISEAL®NS0338NS03382024-11-20
10381780537069CODMAN® BACTISEAL®NS0339NS03392024-11-20
10381780537076CODMAN® BACTISEAL®NS0340NS03402024-11-20
10381780537083CODMAN® BACTISEAL®NS0343NS03432024-11-20
10381780537090CODMAN® HAKIM® BACTISEAL®NS5048NS50482024-11-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00192896122680Schroeder Vulsellum Bone ClampSONTEC INSTRUMENTS, INC.HXD2026-03-10
B356JD259280American MedicalsAmerican MedicalsHXD2026-03-09
00190776416706MillenniumAvalign Technologies, Inc.HXD2026-02-20
00190776415877MillenniumAvalign Technologies, Inc.HXD2026-02-04
00810123209781Adler Instrument CompanyAdler, Inc.HXD2026-01-28
00810123209798Adler Instrument CompanyAdler, Inc.HXD2026-01-28
00841013124532American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124549American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124556American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124563American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00888480670728Timberline Lateral Fusion SystemHighridge Medical, LLCHXD2025-12-18
05060624126697CS Fixed Blade ClampCARE SURGICAL LIMITEDHXD2025-12-17
03662663196741Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
03662663196758Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
03662663196796Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
09421038410479Enztec Inverted Premium Patella ClampENZTEC LIMITEDHXD2025-12-11
09421038410486Enztec Premium Cement Clamp - RotatingENZTEC LIMITEDHXD2025-12-11
00840277133113Innomed, Inc.INNOMED, INC.HXD2025-12-02
00840338603685Tornier HRS MaxTORNIER, INC.HXD2025-11-18
00840338603944Tornier HRS MaxTORNIER, INC.HXD2025-11-18
03662663137027Polaris 4.75 Deformity SystemHighridge Medical, LLCHXD2025-11-14
00840277133038Innomed, Inc.INNOMED, INC.HXD2025-11-12
00885556768471EVOSSmith & Nephew, Inc.HXD2025-11-12
00885556908846EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911112EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911129EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911136EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911143EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911150EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911167EVOSSmith & Nephew, Inc.HXD2025-11-11