FDA.reportPublic FDA data

Positioning Cap

Primary DI
06971538580286
Brand
Positioning Cap
Company
Shenzhen Yingzhi Technology Co.,Ltd.
Model
Lycra-10-20
Published
2023-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230735000Ultimate rTMS; Yingchi rTMSBrain Ultimate, Inc.2023-09-13OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971538580286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971538580286069715385802866971538580286

GMDN Terms#

Term, Definition table
TermDefinition
Head marking capA non-sterile head covering designed as a cap intended to be worn on the head of a patient to allow a healthcare professional to mark specific reference points on the head during a procedure [e.g., transcranial magnetic stimulation (TMS)] as an alternative to marking the scalp directly or to avoid cutting the patient’s hair. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560014166
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971538580033Ultimate rTMSM-30 Ultimate2024-01-16
06971538581047TMS CoilMY90A2024-06-14
06971538581054TMS CoilBY90A2024-06-14
06971538581061TMS CoilBY90B2024-06-14
06971538581078TMS CoilBF90A2024-06-14
06971538580019Ultimate rTMSM-100 Ultimate2024-01-16
06971538580026Ultimate rTMSM-50 Ultimate2023-12-21
06971538580040Ultimate rTMSM-10 Ultimate2023-12-21
06971538580149TMS Coil/2023-12-21
06971538580156TMS Coil CoolerTCC-012023-12-21
06971538580163TMS Coil CoolerTCC-022023-12-21
06971538580309Treatment ChairUniversal2023-12-21
06971538580316Coil ArmUniversal2023-12-21
06971538580323TrolleyM12023-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536901124BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901131BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901148BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901155BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901162BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901179BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
00199536901186BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
10840330706671ProCureTwin Med, LLCFYF2026-05-05
20197344202215MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
20680651497271HalyardO&M HALYARD, INC.FYF2025-10-24
TQ26126151701Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126151991Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126152001Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
10810141933238VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933245VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933252VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933269VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933276VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933283VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933290VIVIT SupplyVivit Supply LLCFYF2024-11-29
10810141933306VIVIT SupplyVivit Supply LLCFYF2024-11-29
10097604414033Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604419014Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604455029Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
10097604474112Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYF2024-08-12
20197344099945MedlineMEDLINE INDUSTRIES, INC.FYF2024-04-11
20197344036483MedlineMEDLINE INDUSTRIES, INC.FYF2023-12-19
30884389102590MedlineMEDLINE INDUSTRIES, INC.FYF2023-10-13