FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780503996
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
PM-8626
Catalog number
PM-8626
Device description
Integra® Miltex® Adson Hemostatic Forceps, 7-1/2", Curved
Published
2020-10-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRQHEMOSTAT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780503996PrimaryGS10
H834PM86260SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178050399610381780503996

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780541585CODMAN® ACCU-FLO®82620282-62022024-05-29
10381780541738CODMAN®82304882-30482024-05-29
10381780536918CODMAN® ACCU-FLO®82152082-15202024-05-29
10381780536925CODMAN® ACCU-FLO®82152182-15212024-05-29
10381780537373CODMAN®82409582-40952024-05-29
10381780537380CODMAN®82859182-85912024-05-29
10381780541578CODMAN® ACCU-FLO®82620182-62012024-05-29
10381780541745CODMAN®82304982-30492024-05-29
10381780090977Integra®961020096102002018-10-26
10381780075073Integra®165002516500252018-09-17
10381780075080Integra®165003016500302018-09-17
10381780075097Integra®165005016500502018-09-17
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826023379MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHRQ2026-10-20
00810143909197SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909265SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909302SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909616SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931777SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931784SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931791SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931807SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931814SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931906SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931920SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931937SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931944SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931951SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931968SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212935089SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143907438SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908725SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908732SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908749SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908756SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909722SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909739SURGIPROSSurgipros, LLCHRQ2026-07-30
00840183532321BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00840183533076BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00810055258567Surgical DesignSurgical Design, Inc.HRQ2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.HRQ2026-06-22
05060212051103Crile Artery Forceps, 145mm StraightDTR MEDICAL LIMITEDHRQ2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatDTR MEDICAL LIMITEDHRQ2026-06-10