FDA.reportPublic FDA data

CODMAN®

Primary DI
10381780511649
Brand
CODMAN®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
201039
Catalog number
20-1039
Device description
CODMAN® Scalp Clip Removal Forceps
Published
2020-02-28
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
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
10886704001171PreviousGS10
10381780511649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670400117110886704001171
1038178051164910381780511649

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)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

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
00381780513547CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28