FDA.reportPublic FDA data

EMERGE MEDICAL & Design

Primary DI
00886020028909
Brand
EMERGE MEDICAL & Design
Company
EMERGE MEDICAL, INC.
Model
398.80.EM
Catalog number
398.80.EM
Device description
PLATE HOLDING FORCEPS WITH SERRATED JAW/ SIZE 0
Published
2015-07-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00886020028909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886020028909008860200289098860200289090886020028909

GMDN Terms#

Term, Definition table
TermDefinition
Implant handling forceps, scissors-likeA hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It has a scissors-like, self-retaining design with ring handles, is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078642955
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886020026417EMERGE MEDICAL & Design319.293.EM319.293.EM2015-07-08
00886020026431EMERGE MEDICAL & Design319.292.EM319.292.EM2015-07-08
00886020026455EMERGE MEDICAL & Design319.38.EM319.38.EM2015-07-08
00886020026479EMERGE MEDICAL & Design319.35.EM319.35.EM2015-07-08
00886020026554EMERGE MEDICAL & Design319.46.EM319.46.EM2015-07-08
00886020026899EMERGE MEDICAL & Design309.501.EM309.501.EM2015-07-08
00886020008109EMERGE MEDICAL & Design211.841.EM211.841.EM2015-07-07
00886020008116EMERGE MEDICAL & Design211.842.EM211.842.EM2015-07-07
00886020008123EMERGE MEDICAL & Design211.843.EM211.843.EM2015-07-07
00886020008130EMERGE MEDICAL & Design211.844.EM211.844.EM2015-07-07
00886020008147EMERGE MEDICAL & Design211.845.EM211.845.EM2015-07-07
00886020008154EMERGE MEDICAL & Design211.846.EM211.846.EM2015-07-07
00886020008161EMERGE MEDICAL & Design211.847.EM211.847.EM2015-07-07
00886020008178EMERGE MEDICAL & Design211.848.EM211.848.EM2015-07-07
00886020008185EMERGE MEDICAL & Design211.849.EM211.849.EM2015-07-07
00886020008284EMERGE MEDICAL & Design211.810.EM211.810.EM2015-07-07
00886020008291EMERGE MEDICAL & Design211.811.EM211.811.EM2015-07-07
00886020008307EMERGE MEDICAL & Design211.812.EM211.812.EM2015-07-07
00886020008314EMERGE MEDICAL & Design211.813.EM211.813.EM2015-07-07
00886020008321EMERGE MEDICAL & Design211.814.EM211.814.EM2015-07-07

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