FDA.reportPublic FDA data

Manus Medical, LLC

Primary DI
00811870037986
Brand
Manus Medical, LLC
Company
Manus Medical, LLC
Model
UNC-9800-0
Device description
"WIRE CUTTING SCISSORS 4..75"""
Published
2024-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JYAScissors, Wire Cutting, Ent, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYAScissors, Wire Cutting, Ent, SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870037980PackageGS1200In Commercial Distribution
00811870037986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003798020811870037980
00811870037986008118700379868118700379860811870037986

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, single-useA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
800604196
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811870037979Manus Medical, LLCZZ-0683-12024-02-06
00811870033216Custom Healthcare Systems Inc.UNC-179142018-07-25
00811870035555Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
00811870030703Custom Healthcare Systems Inc.VBS-18520C2018-10-19
00811870032943CUSTOM HEALTHCARE SYSTEMS, INCDT-0520192019-06-03
00811870034411Custom Healthcare Systems Inc.VBS-18520B2018-10-19
00811870035036Custom Healthcare Systems, Inc.DT-197142020-04-09
00811870035166Custom Healthcare Systems, Inc.CUS1365-022020-07-28
00811870035630Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
00811870035661Custom Healthcare Systems of VA, LLCDT-193432021-07-15
00811870035883Custom Healthcare Systems Inc.VBS-191082019-03-07
00811870035890Custom Healthcare Systems Inc.11168030152019-03-07
00811870037863Manus Medical, LLCEMLP-20375-12023-12-20
20811870037980Manus Medical, LLCUNC-9800-02024-02-07
20811870037973Manus Medical, LLCZZ-0683-12024-02-06
00811870037887Manus Medical, LLCLPGM-0012024-02-02
00811870037900Manus Medical, LLCLPGM-002-12024-02-02
00811870037917Manus Medical, LLCMMCUS11732024-02-02
00811870037924Manus Medical, LLCA2081V-72024-02-02
00811870037948Manus Medical, LLCB9-18847-12024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20811870037980Manus Medical, LLCManus Medical, LLCJYA2024-02-07
10888439920574CARDINAL HEALTHCardinal Health 200, LLCJYA2021-01-29
50888439920572CARDINAL HEALTHCardinal Health 200, LLCJYA2021-01-29
04038653149063DUROTIPAesculap AGJYA2020-04-21
04038653038312AESCULAPAesculap AGJYA2020-04-20
00888118014429SCISSORSKLS-Martin L.P.JYA2018-09-26
00888118014436SCISSORSKLS-Martin L.P.JYA2018-09-26
00888118014443SCISSORSKLS-Martin L.P.JYA2018-09-26
10885403012525V. MuellerSTERIS CORPORATIONJYA2018-08-02
10885403010811V. MuellerSTERIS CORPORATIONJYA2018-07-13