FDA.reportPublic FDA data

Grafco

Primary DI
M36828051
Brand
Grafco
Company
GF HEALTH PRODUCTS, INC.
Model
2805
Catalog number
2805
Device description
NASAL SPECULUM VIENNA ADULT
Published
2021-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBESnare, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBESnare, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M36828051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770404049Bausch + LombBausch & Lomb IncorporatedKBE2025-07-29
00757770405671Bausch + LombBausch & Lomb IncorporatedKBE2025-07-29
00887482174951Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBE2024-08-15
00887482192757Symmetry ASPEN SURGICAL PRODUCTS, INC.KBE2024-08-15
00887482192764Symmetry ASPEN SURGICAL PRODUCTS, INC.KBE2024-08-15
00887482192771Symmetry ASPEN SURGICAL PRODUCTS, INC.KBE2024-08-15
G586E7726310Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
G586E7726320Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
G586E7726330Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
G586E97726310Novo SurgicalNOVO SURGICAL, INC.KBE2023-12-18
00842962149355HNM MEDICALHNM STAINLESS, LLC.KBE2023-04-06
00842962149362HNM MEDICALHNM STAINLESS, LLC.KBE2023-04-06
14026704808875PILLINGTELEFLEX INCORPORATEDKBE2022-12-08
14026704808868PILLINGTELEFLEX INCORPORATEDKBE2022-12-08
54026704808873PILLINGTELEFLEX INCORPORATEDKBE2022-12-08
00842331177804Novo Surgical Inc. NOVO SURGICAL, INC.KBE2022-11-14
00887482042861Symmetry KrauseASPEN SURGICAL PRODUCTS, INC.KBE2022-09-30
G043799000BEARBear-Ent, LLCKBE2022-08-02
G043799010BEARBear-Ent, LLCKBE2022-08-02
00190776048624AvalignAvalign Technologies, Inc.KBE2021-11-03
M36828031GrafcoGF HEALTH PRODUCTS, INC.KBE2021-06-03
00840113215102Richard-Allan® Nasal SnareASPEN SURGICAL PRODUCTS, INC.KBE2021-02-25
00840113215126Richard-Allan® Nasal SnareASPEN SURGICAL PRODUCTS, INC.KBE2021-02-25
00840113215119Richard-Allan® Nasal SnareASPEN SURGICAL PRODUCTS, INC.KBE2021-02-25
00840113215133Richard-Allan® Nasal SnareASPEN SURGICAL PRODUCTS, INC.KBE2021-02-25
00190660173609Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173616Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173661Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173678Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04
00190660173685Ambler SurgicalAMBLER SURGICAL CORP.KBE2021-01-04