FDA.reportPublic FDA data

Symmetry Raney

Primary DI
00887482192641
Brand
Symmetry Raney
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
57-8501
Catalog number
57-8501
Device description
Symmetry® Clip, Raney Scalp, (12/unit)
Published
2024-08-20
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
00887482192641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482192641008874821926418874821926410887482192641

GMDN Terms#

Term, Definition table
TermDefinition
General skin wound clipA metallic surgical instrument intended to be used to approximate the edges of any skin wound (non-dedicated) to facilitate wound healing and/or for the placement of sutures. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
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
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780540571CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2026-04-15
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
00381780513547CODMANINTEGRA LIFESCIENCES PRODUCTION CORPORATIONHBO2020-02-28