FDA.reportPublic FDA data

Buxton Wrist Retractor Blade, 30mm Assy, Net

Primary DI
00810105030518
Brand
Buxton Wrist Retractor Blade, 30mm Assy, Net
Company
COMPOSITE MANUFACTURING, INC.
Model
1-8001-115-001
Device description
30mm x 30mm radiolucent carbon fiber retractor
Published
2021-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810105030518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810105030518008101050305188101050305180810105030518

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9493617580info@carbonfiber.com

Regulatory Flags#

DUNS number
947090650
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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00810105030648"Skytron Split Leg Pad Set 2"""4-030-70-2S2024-03-22
00810105030655"Skytron Split Leg Pad Set 3"""4-030-70-3S2024-03-22
00810105030662"Skytron Split Leg Pad Set 4"""4-030-70-4S2024-03-22
00810105030679"Skytron Split Leg Pad Set 5"""4-030-70-5S2024-03-22
00810105030006Orthopedic Fracture Attachment Kit, Berchtold3-1000-001OZ 75317752021-06-14
00810105030013Euro Orthopedic Fracture Attachment3-2006-001OZ 75317042020-03-24
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00810105030761Pediatric Arm and Hand Table No Pad1-1015-0052024-05-13
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00810105030730CMI Spine Frame Head Foam Supports (12 Pack)4-0009-2032024-04-25
00810105030747CMI Spine Frame Arm Covers (12 Pack)4-0009-2042024-04-25
00810105030723Multi Posture Armboard Kit1-1024-0012024-04-03
00810105030587Trigger Lite Armboard2-010-102024-03-22
00810105030594"Trigger Lite Armboard Pad 2"""2-010-10-2WS2024-03-22
00810105030600"Trigger Lite Armboard Pad 3"""2-010-10-3WS2024-03-22
00810105030617"Trigger Lite Armboard Pad 4"""2-010-10-4WS2024-03-22
00810105030624"Trigger Lite Armboard Pad 5"""2-010-10-5WS2024-03-22

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