FDA.reportPublic FDA data

Anmuth Medical International

Primary DI
08403207110121
Brand
Anmuth Medical International
Company
Anmuth Medical International, LLC
Model
30-110-12
Catalog number
30-110-12
Device description
DERF Needle Holder 12cm/4.75"
Published
2023-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDFGUIDE, NEEDLE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08403207110121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08403207110121084032071101218403207110121

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.75Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(413)478-9876marc@anmuthmedical.com

Regulatory Flags#

DUNS number
786500830
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08403207009500Anmuth Medical International39-110-0039-110-002025-06-09
08403207009517Anmuth Medical International39-112-0039-112-002025-06-09
08403207009524Anmuth Medical International39-138-0039-138-002025-06-09
08403207009579Anmuth Medical International39-172-0039-172-002025-06-09
08403207009647Anmuth Medical International39-311-2039-311-202025-06-09
08403207009807Anmuth Medical International39-525-0639-525-062025-06-09
08403207010032Anmuth Medical International39-539-0339-539-032025-06-09
08403207010162Anmuth Medical International39-546-54TC39-546-54TC2025-06-09
08403207010179Anmuth Medical International39-547-24TC39-547-24TC2025-06-09
08403207010261Anmuth Medical International39-557-2539-557-252025-06-09
08403207010278Anmuth Medical International39-559-40TC39-559-40TC2025-06-09
08403207010285Anmuth Medical International39-559-47TC39-559-47TC2025-06-09
08403207010292Anmuth Medical International39-560-57TC39-560-57TC2025-06-09
08403207010346Anmuth Medical International39-630-0039-630-002025-06-09
08403207010353Anmuth Medical International39-633-2039-633-202025-06-09
08403207010360Anmuth Medical International39-635-1739-635-172025-06-09
08403207010377Anmuth Medical International39-650-2339-650-232025-06-09
08403207010384Anmuth Medical International39-666-0639-666-062025-06-09
08403207009531Anmuth Medical International39-160-0039-160-002025-06-05
08403207009548Anmuth Medical International39-161-1339-161-132025-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663161220PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCGDF2026-02-16
03662663161237PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCGDF2026-02-16
03662663161961Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2026-02-16
00850031983014OCCIGUIDEVAULT PARAGON GROUP, INC.GDF2026-01-07
03662663244442Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663244466Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663276412Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276429Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276788Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-11-17
03662663135924Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCGDF2025-11-14
20197344044792MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
20197344044808MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
00194613059095MSI Precision Specialty InstrumentsMed Saver, Inc.GDF2025-08-01
10850012846434PicoDriverLSI Solutions, Inc.GDF2025-07-19
05010058179820InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182639InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182646InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058183643InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182622InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-18
05010058178953InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
05010058179943InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
04049047675808GimmiGimmi GmbHGDF2025-05-06
04049047675815GimmiGimmi GmbHGDF2025-05-06
04049047675884GimmiGimmi GmbHGDF2025-05-06
04049047675891GimmiGimmi GmbHGDF2025-05-06
04049047675907GimmiGimmi GmbHGDF2025-05-06
04049047675945GimmiGimmi GmbHGDF2025-05-06
04049047675952GimmiGimmi GmbHGDF2025-05-06
04049047675969GimmiGimmi GmbHGDF2025-05-06
04049047675976GimmiGimmi GmbHGDF2025-05-06