FDA.reportPublic FDA data

CODMAN

Primary DI
00381780511581
Brand
CODMAN
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
20-1025
Catalog number
201025
Device description
CODMAN RANEY Scalp Clips
Published
2020-02-28
Public version status
New
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
HBOCLIP, SCALP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBOClip, ScalpNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886704001116PreviousGS10
10381780511588PrimaryGS10
00381780511581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088670400111620886704001116
1038178051158810381780511588
00381780511581003817805115813817805115810381780511581

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
DM exempt
true
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
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
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
00381780513547CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28