FDA.reportPublic FDA data

Tealmed

Primary DI
06974546524365
Brand
Tealmed
Company
Ningbo Tealmed Emergency Products Co., Ltd.
Model
#DH-3692
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZYHammer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZYHammer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974546524365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974546524365069745465243656974546524365

GMDN Terms#

Term, Definition table
TermDefinition
Percussion hammer, manual, reusableA hand-held manual instrument designed to be used by an examining physician to gently tap near a patient's joints to test reflexes (e.g., patellar, ankle reflexes). It consists of a handle and shaft typically made of stainless steel, and has a head that may be ring, wedge, or dome shaped and is made of a soft material (e.g., rubber or plastic). Some devices may be fitted with a spike, brush, or other detachable component at the proximal end that can be used for neurological examinations. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421289586
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974546523177Tealmed#DS-92992026-04-28
06974546525133Tealmed#IS-52242026-04-21
06974546524372Tealmed#DH-36952026-01-16
06974546525126Tealmed#IS-52092025-08-29
06974546523160Tealmed#DS9290-PK2025-07-21
06974546525119Tealmed#IS-52182025-05-22
06974546523153Tealmed#DS9290-BL2025-05-12
06974546525102Tealmed#IS-53242025-04-27
06974546527182Tealmed#KB-4137-W2025-03-20
06974546527175Tealmed#KB-10882024-12-16
06974546523122Tealmed#DS-92982024-09-23
06974546523139TealmedDS-9291-BK2024-09-23
06974546523146Tealmed#DS-9291-BL2024-09-23
06974546523115TealmedDS-9295-BR2024-08-20
06974546523108Tealmed#DS-92942024-07-31
06974546523092Tealmed#DS-9295-BK2024-06-25
06974546523078Tealmed#DS-9295-PU2024-05-06
06974546523085TealmedDS-9295-HG2024-05-06
06974546523061TealmedDS-9295-BL2024-04-10
06974546523054TealmedDS-9295-RD2024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091179ELMED INCORPORATEDELMED INCORPORATEDFZY2026-06-03
00810189451162Surgical DesignSurgical Design, Inc.FZY2026-05-23
00810189451483Surgical DesignSurgical Design, Inc.FZY2026-05-23
00198506089114ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
00198506089411ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
10705034579023N/AMedos International SàrlFZY2026-03-05
00840493416472LUX Expandable Interbody SystemXENIX MEDICAL LLCFZY2026-02-24
03662663083638ActivLHighridge Medical, LLCFZY2026-02-03
03662663083645ActivLHighridge Medical, LLCFZY2026-02-03
03662663083652ActivLHighridge Medical, LLCFZY2026-02-03
03662663083669ActivLHighridge Medical, LLCFZY2026-02-03
03662663083676ActivLHighridge Medical, LLCFZY2026-02-03
03662663083690ActivLHighridge Medical, LLCFZY2026-02-03
03662663155618Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155762Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155779Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663244695Vital MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-12-18
04262494463150N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463174N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463167N/ADoppkon GmbH & Co. KGFZY2025-11-28
03662663216951Telluride MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-11-17
03662663267205Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663267601Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663279123Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
00196449034604Anatomic Access LLIFTyber Medical, LLCFZY2025-10-22
00198506085741ELMED INCORPORATEDELMED INCORPORATEDFZY2025-09-19
04059453096517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFZY2025-08-25
04262494460562N/ADoppkon GmbH & Co. KGFZY2025-08-05
10889981322144REEF LSeaspine Orthopedics CorporationFZY2025-07-15
00199150021550Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FZY2025-07-13