FDA.reportPublic FDA data

Lid implant (lid chain)

Primary DI
04250381807231
Brand
Lid implant (lid chain)
Company
Spiggle & Theis Medizintechnik GmbH
Model
1500-14
Catalog number
1500-14
Device description
Lid implant (lid chain) Platinum/Iridium according to Berghaus/Schrom, 1.4 g, sterile, 1 piece
Published
2015-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMLWeights, Eyelid, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMLWeights, Eyelid, ExternalOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021750000LID CHAIN EYELID WEIGHTSJedmed Instrument Co.2003-01-27MML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250381807231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381807231042503818072314250381807231

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid weight, implantableAn ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1.4Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage must protect from dust, moisture and contamination. Avoid direct sunlight during storage.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49220690810info@spiggle-theis.de

Regulatory Flags#

DUNS number
332893028
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250676736000Fiberglass light carrier50-231-0150-231-012025-09-15
04250676736024Fiberglass light carrier50-231-0350-231-032025-09-15
04250676736031Fiberglass light carrier50-234-0150-234-012025-09-15
04250676736055Fiberglass light carrier50-234-0350-234-032025-09-15
04250381858387Fiberglass light carrier for rigid and50-205-1250-205-122022-09-27
04250381858394Fiberglass lightcarrier for rigid and50-205-3650-205-362022-09-27
04250381858400Fiberglass lightcarrier for rigid and50-205-7050-205-702022-09-27
04250381858509Fiberglass lightcarrier for laser50-217-1250-217-122022-09-27
04250381858516Fibreglass light carrier for laser50-217-3650-217-362022-09-27
04250381858523Fiberglass lightcarrier for laser50-217-7050-217-702022-09-27
04250676736048Fiberglass light carrier50-234-0250-234-022022-09-27
04250676701800Fibre light carrier20-155-0020-155-002022-09-14
04250676748188Endoragard teeth protector50-240-0050-240-002026-04-27
04250676748195Medasil teeth protector50-250-0050-250-002022-09-27
04050659354647Brünings anastignatic aural magnifier10-180-0010-180-002026-01-21
04250676747204Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04250676747211Tray set with flex band1000617-31000617-32025-12-03
04250676747235Filter modul with 8 x LM10-845-0110-845-012025-12-03
04250676747228Tray set1000617-3-01000617-3-02025-12-03
04251993600128Filter modul with 8 x LM10-845-0110-845-012025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EHKM80001111Test Weight Set Upper Eyelid ImplantHeinz Kurz GmbHMML2026-04-07
00813142021303BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021310BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021327BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021334BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021341BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021358BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021365BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021372BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021389BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021396BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021402BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021419BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021426BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021433BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021440BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021457BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021464BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021471BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021488BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021495BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021501BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021518BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021525BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021532BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021549BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021556BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021563BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021570BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021587BlinkezeMEDDEV CORPORATIONMML2023-11-28