FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780159940
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
26591
Catalog number
26-591
Device description
Integra® Miltex® Raney Reusable Scalp Clips - (12/pack)
Published
2016-08-03
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
HBOCLIP, SCALP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBOClip, ScalpNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033660000STORZ RANEY SCALP CLIP, MODEL 1-20-004-05Rudolf Storz GmbH2004-01-07HBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780159940PrimaryGS10
H834265911SecondaryHIBCC0
00381780159943Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178015994010381780159940
00381780159943003817801599433817801599430381780159943

GMDN Terms#

Term, Definition table
TermDefinition
Scalp haemostasis clip, reusableA small, manually-operated and applied surgical device used to stop bleeding from the scalp during surgery on the cranium. It is is usually applied to the scalp using the fingers or a dedicated pair of scalp clip forceps, and consists of two blades that are joined at a midpoint or is made of a single alpha-shaped part. It is typically made of high-grade stainless steel. This is a reusable device.

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
12
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780540571CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2026-04-15
00887482192641Symmetry RaneyASPEN SURGICAL PRODUCTS, INC.HBO2024-08-20
00842962110638HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110645HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110652HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110669HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110676HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110683HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110690HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110706HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110713HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110720HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00842962110737HNM MEDICALHNM STAINLESS, LLC.HBO2023-03-30
00721902371592N/AMEDTRONIC PS MEDICAL, INC.HBO2020-09-12
70721902371591N/AMEDTRONIC PS MEDICAL, INC.HBO2020-09-12
10381780511632CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-04-01
00381780511635CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-04-01
10381780511588CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
10381780511595CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
10381780511601CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
10381780511618CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
10381780511625CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
10381780513544CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
10381780513551CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
00381780511581CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
00381780511598CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
00381780511604CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
00381780511611CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
00381780511628CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28
10381780511649CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28