FDA.reportPublic FDA data

Oxboro ™ DuoGuard™ Instrument Tip Protectors

Primary DI
00840113207145
Brand
Oxboro ™ DuoGuard™ Instrument Tip Protectors
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
093027BBG
Device description
Designed to protect medical instruments from damage during sterilization, storage, and handling
Published
2021-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113207145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113207145008401132071458401132071450840113207145

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-use, sterileA sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. 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
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840113242754BovieSEVL2026-09-18
10840113242778BovieSERFS2026-09-18
10840113242785BovieSEPAT2026-09-18
10840113242792BovieSEPA2026-09-18
10840113242983VALLEYLAB™E156042026-09-18
10840113242990VALLEYLAB™E155942026-09-18
10840113243034VALLEYLAB™E156242026-09-18
10840113243058VALLEYLAB™E156142026-09-18
10840113243072VALLEYLAB™E165142026-09-18
10840113243089VALLEYLAB™E165122026-09-18
10840113243096VALLEYLAB™E156262026-09-18
00840113233281BovieH1002026-09-04
00840113233304BovieH1012026-09-04
00840113233328BovieH101-ADH2026-09-04
00840113233342BovieH1032026-09-04
00840113233366BovieH1042026-09-04
00840113233380BovieH1052026-09-04
00840113233403BovieH1062026-09-04
00840113233427BovieH1092026-09-04
00840113233441BovieH1102026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
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