FDA.reportPublic FDA data

Sterion®Clamp Cover Fabric

Primary DI
00887761000520
Brand
Sterion®Clamp Cover Fabric
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
072004PBX
Device description
Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile).
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887761000527PackageGS110In Commercial Distribution
00887761000520PrimaryGS10
80887761000526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088776100052710887761000527
00887761000520008877610005208877610005200887761000520
8088776100052680887761000526

GMDN Terms#

Term, Definition table
TermDefinition
Clamp jaw cover, sterileA sterile device used in pairs that are placed/fitted onto the distal working end (the jaws) of surgical instruments (e.g., vascular clamps, haemostats and forceps) to provide improved atraumatic grip and even pressure distribution when clamping an artery or a vein. It is typically a long device designed as a cylindrical tube and made of radiopaque silicone materials; it is available in various sizes. It may also be known as jaw covers. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814707023817Protek1-519-1028B2026-02-16
00840113231867Bard-ParkerST-1002026-02-15
00887482023389Symmetry53-16622026-02-15
00887482023396Symmetry53-16632026-02-15
00887482023402Symmetry53-16642026-02-15
00887482138373Sterion10-00-752026-02-15
00887482156186Symmetry53-1662T2026-02-15
00887482156223Symmetry53-1664T2026-02-15
20887482023376Symmetry53-16612026-02-15
10607151000100BOVIE001000102016-10-10
10607151000117BOVIE001100112016-10-10
10607151000124BOVIE001200122016-10-10
10607151001428BOVIEA1204PA1204P2016-10-12
10607151001534BovieA802EUA802EU2016-10-19
10607151001541BOVIEA1252CA1252C2016-10-12
10607151001589BovieA1255AA1255A2016-09-28
10607151002258BovieNLOTNLOT2017-02-10
10607151002579BOVIEA1254CA1254C2016-10-12
10607151004733BOVIEA1202A12022016-10-12
10607151004801BovieFSSEPFSSEP2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482138373SterionASPEN SURGICAL PRODUCTS, INC.KDC2026-02-15
10653160391098Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDC2025-12-19
06946480584224Disposable Skin Staple Removers Sinolinks Medical Innovation Co., Ltd.KDC2025-09-04
00194613020576MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613043209MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613044381MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
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00194613045296MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045302MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613045531MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
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00194613091774MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01
00194613093228MSI Precision Specialty InstrumentsMed Saver, Inc.KDC2025-08-01