FDA.reportPublic FDA data

InHealth Technologies; Katz

Primary DI
00848253002637
Brand
InHealth Technologies; Katz
Company
Freudenberg Medical, LLC
Model
FB 5000
Published
2017-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00813307013594PackageGS15In Commercial Distribution
00848253002637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813307013594008133070135948133070135940813307013594
00848253002637008482530026378482530026370848253002637

GMDN Terms#

Term, Definition table
TermDefinition
ENT foreign body inflatable extractorA non-sterile, manual device intended to be inserted into the nasal or ear canal for the extraction of a foreign body/debris. It is a thin tube with a proximal inflation mechanism (e.g., a syringe) and a distal balloon. The distal end is intended to be navigated past the foreign body, after which the balloon is inflated and then pulled back along the canal to dislodge the foreign body. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-477-5969InHealth@inhealth.com

Regulatory Flags#

DUNS number
120981337
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00850004312001EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-100PN1007960-1002021-06-15
00850004312049Steerable Introducer Sheath 12FSS120065PN1008533-0042020-01-13
00850004312018Steerable Introducer Sheath 8.5F Small CurlSS085075SPN1008533-0012019-10-25
00850004312025Steerable Introducer Sheath 8.5F Medium CurlSS085075MPN1008533-0022019-10-25
00850004312032Steerable Introducer Sheath 8.5F Large CurlSS085075LPN1008533-0032019-10-25
00848253003634InHealth Technologies; Blom-SingerPK 21062019-07-10
00848253003641InHealth Technologies; Blom-SingerPK 21072019-07-10
00848253003399InHealth Technologies; Blom-SingerPK 21002019-06-07
00848253003405InHealth Technologies; Blom-SingerPK 21012019-06-07
00848253003412InHealth Technologies; Blom-SingerPK 21022019-06-07
00848253003429InHealth Technologies; Blom-SingerPK 21032019-06-07
00848253003436InHealth Technologies; Blom-SingerPK 21042019-06-07
00848253003443InHealth Technologies; Blom-SingerPK 21052019-06-07
00813307012597InHealth Technologies; Blom-SingerBE 60452018-01-01
00813307012603InHealth Technologies; Blom-SingerBE 60462018-01-01
00813307012634InHealth Technologies; Blom-SingerBE 60412018-01-01
00813307012641InHealth Technologies; Blom-SingerBE 60422018-01-01
00813307012658InHealth Technologies; Blom-SingerBE 60432018-01-01
00813307012665InHealth Technologies; Blom-SingerBE 60442018-01-01

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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
M36828051GrafcoGF 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