FDA.reportPublic FDA data

CODMAN

Primary DI
10886704001171
Brand
CODMAN
Company
Cerenovus, Inc.
Model
20-1039
Catalog number
201039
Device description
CODMAN Scalp Clip Removal Forceps
Published
2016-06-30
Public version status
Update
Distribution status
Not 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
K905433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905433000CODMAN DISPOSABLE SCALP CLIP APPLIERCodman & Shurtleff, Inc.1991-02-21HBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704001171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670400117110886704001171

GMDN Terms#

Term, Definition table
TermDefinition
Scalp clip forcepsA hand-held, manually-operated, surgical instrument used to manually apply and remove haemostatic scalp clips (reusable or single-use) from the scalp during or after a surgical intervention on the cranium/scalp. It is typically a scissors-like device with ring handles, and may or may not be self-retaining. The working end of the device will typically have dedicated grasping blades that are profiled/designed to accommodate a compatible scalp clip. The device is available in various sizes and 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)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704085317TRUFILL632500NA632500NA2023-10-23
10886704085324TRUFILL632400NA632400NA2023-10-23
10886704029144TRUFILL631-400631-4002014-09-20
10886704029151TRUFILL631-500631-5002014-09-20
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086512CEREGLIDENIC57125UNIC57125U2025-09-26
10886704086536CEREGLIDENIC57132UNIC57132U2025-09-26
10886704086550CEREGLIDENIC57137UNIC57137U2025-09-26
10886704086598CEREGLIDENIC42125U2025-09-26

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