FDA.reportPublic FDA data

AED ETH1592-RN Romeo Needle Holder, 5mm x 33cm

Primary DI
00848657076043
Brand
AED ETH1592-RN Romeo Needle Holder, 5mm x 33cm
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
ETH1592-RN
Catalog number
ETH1592-RN
Device description
A 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.
Published
2023-05-18
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
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657076043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657076043008486570760438486570760430848657076043

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(818) 227-2720customerservice@aed.md

Regulatory Flags#

DUNS number
839138955
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
00848657078368AEDAED UH8012026-04-23
00848657078276AEDAED 33310UL-R2026-04-13
00848657078283AEDAED 33310UL2026-04-13
00848657078290AEDAED 33321A-R2026-04-13
00848657078306AEDAED 33321A2026-04-13
00848657078313AEDAED 33310FG-R2026-04-13
00848657078320AEDAED 33310FG2026-04-13
00848657078337AEDAED 33310R-R2026-04-13
00848657078344AEDAED 33310R2026-04-13
00848657078351AEDAED 34321SL2026-04-13
00848657078269AEDJZM15922026-03-02
00848657078238AED8830BL2026-02-24
00848657078245AED8830CL2026-02-24
00848657078252AED8830FL2026-02-24
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810212931654SURGIPROSSurgipros, LLCFHQ2026-06-01
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00810055250745Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250752Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250783Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250790Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250806Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250813Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250820Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250844Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250851Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250882Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250905Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250912Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450028Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450035Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450066Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450073Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450080Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450103Surgical DesignSurgical Design, Inc.FHQ2026-05-29
G149TBSB7370TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7380TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7390TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7400TBS BASICSACME ENTERPRISE.FHQ2026-05-21
08961104621824Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621831Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621848Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621855Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621862Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21