FDA.reportPublic FDA data

ELMED

Primary DI
00842180195912
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST231887
Catalog number
ST231887
Device description
"Burgess Carpal Tunnel Retractor, Overall Length: 4.25"" (10,8 cm), Blade Length: 12 mm, Blade Depth: 8 mm"
Published
2024-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180195912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180195912008421801959128421801959120842180195912

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
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket 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
00198506091667ELMED INCORPORATED32-509-04-I32-509-04-I2026-07-10
00198506091759ELMED INCORPORATED31430-00B31430-00B2026-07-10
00198506091803ELMED INCORPORATEDSTE3220413IVSTE3220413IV2026-07-10
00198506091810ELMED INCORPORATED31960-3131960-312026-07-10
00198506091827ELMED INCORPORATEDSTE321211AISTE321211AI2026-07-10
00198506091834ELMED INCORPORATEDSTE321212AISTE321212AI2026-07-10
00198506091841ELMED INCORPORATED31960-3631960-362026-07-10
00198506091858ELMED INCORPORATED31960-6331960-632026-07-10
00198506091865ELMED INCORPORATED20-2771820-277182026-07-10
00198506091872ELMED INCORPORATED9839FS9839FS2026-07-10
00198506091889ELMED INCORPORATED31560-2131560-212026-07-10
00198506091612ELMED INCORPORATED24129-10B-KW24129-10B-KW2026-06-24
00198506091629ELMED INCORPORATED24129-08B-KW24129-08B-KW2026-06-24
00198506091506ELMED INCORPORATED53020-7853020-782026-06-10
00198506091513ELMED INCORPORATEDSTE3212113ISTE3212113I2026-06-10
00198506091520ELMED INCORPORATEDSTE3212313ISTE3212313I2026-06-10
00198506091537ELMED INCORPORATED32007-1532007-152026-06-10
00198506091544ELMED INCORPORATED32006-1532006-152026-06-10
00198506091551ELMED INCORPORATED23-2503LH23-2503LH2026-06-10
00198506091575ELMED INCORPORATED23-6020-1323-6020-132026-06-10

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